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The other day, I was having an email conversation with a friend about business goals.

She mentioned that she'd started a book only to realize she didn't

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

want to write one *right now* after all.

She had mixed feelings about the decision, though. After all, *everyone* says a good consultant

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

*must* write a book. And she was feeling the pressure.

In a reply email, I offered her a piece of advice that, as soon as I'd typed it, I knew was really

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

advice for *me* and not her.

Have you ever had that happen? You're talking with someone and you hear yourself making a suggestion that y

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ou realize (on the spot or later on) is exactly what *you* needed to hear?

This final newsletter ingredient continues to be the hardest for me
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro
rong>--I grapple with it in nearly every issue. See, persistence, and staying the course with your newsletter, is all about keeping your focus on the thin
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
s that matter. Not letting yourself get distracted by all those *other* great ideas. The sections you *could* add to your newsletter. The design changes y
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
ou *could* make. The requests and reviews and ... that *might* be good to include.

I find myself going around in circles some weeks--not
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
wanting to start the newsletter, and yet being on a deadline and *needing* to start the newsletter. And, each time I get caught in this circle, the soluti
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
n is consistently the same. Yet, it often takes me several hours to *realize* that I know how to resolve my procrastination.

For me, what works most ofte
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
is to STOP what I'm doing (surfing the Internet for ideas, reading someone else's book or newsletter, asking someone else what they think I should write
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
about, reviewing back issues) and to simply SIT for a few minutes.

I know that's the solution. And I know it works 9 times out of 10. And yet, I still fi
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
d myself unwilling to apply it at the first sign of distress.

Then again, I'm the same way about taking medicine ;-). I have to get really, really, reall
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
sick before I even think of taking something.

So often, we think of persistence as working harder, as pushing through it, as forcing ou
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
rselves to buckle down and "get it done." And there's value to that.

But, in this case, I'm speaking of persistence as more of a willingness to r
t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
peat those actions you already *know* work for you. So, if you know that a plain text newsletter format works best for you, don't let yourself wo
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
der if you should publish in HTML every few months. If you know your readers respond best when you talk about your dog, don't listen to that consultant wh
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
o tells you to be more buttoned up.

By persistence, I'm asking you to commit to blazing your own trail--doing things your own way. Persi
.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
t in that. And don't worry about what everyone says, or what works for everyone else.

P.S. If you find a magical formula for this kind of persistence, I'
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
all ears ;-).

Your challenge: Today apply that piece of advice you find yourself repeating, but *never* applying in your own newsletter

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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Just Other Articles - Successful Newsletter Publishing: Keep Your Focus on What Matters

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